SEDEC: Mobile X-ray system SM_40HF_BDC not water-resistant; must follow cleaning instructions to avoid damage. Recall covers specific serial numbers.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
SEDECAL's mobile X-ray system SM_40HF_BDC is not water-resistant and requires strict cleaning per the manual. Improper cleaning could cause damage to the equipment.
The system is not water-resistant, so exposure to water or improper cleaning could damage it. Following the manual's cleaning instructions is necessary to prevent equipment failure.
Users of the SEDECAL SM_40HF_BDC mobile X-ray system with serial numbers starting with 31526 are affected. Medical facilities using this model are most at risk.
Check for the model SM_40HF_BDC and serial numbers starting with 31526. The equipment was sold with UDI/DI 08436046001510.
Review the manual for proper cleaning procedures to avoid damage.
Yes, improper cleaning could damage the equipment.
Check for model SM_40HF_BDC and serial numbers starting with 31526.
Follow the cleaning instructions in the manual to avoid damage.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0286-2026 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-0286-2026 from SEDECAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.